PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer

Prostate Cancer Clinical Trial

— PROMISE-PET  

Official title:

PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320223
• Other study ID #: PROMISE PET Registry
• Status: Recruiting
• Start date: March 5, 2024
• Est. completion date: March 5, 2035

Study information

• Verified date: March 2024
• Source: University Hospital, Essen
• Contact: Wolfgang P Fendler, M.D.
• Phone: +492017232032
• Email: redcap[@]ikim.nrw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background:

PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.

Need:

Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.

Aim:

1. To assess the prognostic value of PSMA PET

2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stages

Inclusion:

• Adult patients with

• biopsy/histo proven prostate cancer who

• underwent PSMA PET (any type)

• for staging or re-staging at any stage and who

• have at least 3-year overall survival follow-up data available will be included consecutively.

Exclusion:

• Patients with neuroendocrine prostate cancer

• Patients with metastasized or disseminated malignancy other than prostate cancer

Description:

Background:

Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) Positron-Emission-Tomography (PET) whole-body stage of prostate cancer [Seifert et al. European Urology 2023]. PSMA PET disease extent by PROMISE has been associated with relevant oncologic outcome, specifically overall survival in patients with various stages of prostate cancer.

Need:

Improved risk assessment across various stages of prostate cancer is urgently needed for guidance of clinical management and prospective study design.

Aim:

1. To assess the prognostic value of PSMA PET, summarized by PROMISE [Seifert et al EurUrol23]

2. To compare the prognostic value of PSMA PET with established clinical prognostic scores in patients with prostate cancer at various disease stages

3. To assess the association of PSMA PET stage with management, laboratory findings, histopathology findings or patient characteristics

Eligibility:

Adult patients with biopsy/histo proven prostate cancer who underwent PSMA PET for staging at various stages will be included consecutively. All stages will be included: Primary (Initial Staging), BCR (Biochemical Recurrence), nmCRPC (conventional non-metastatic castration-resistant prostate cancer), mHSPC (conventional metastatic hormone-sensitive prostate cancer), mCRPC (conventional metastatic castration-resistant prostate cancer) and advanced mCRPC.

Inclusion:

• Adult patients with

• histopathology proven prostate cancer who

• underwent PSMA PET (any type)

• for staging or re-staging at any stage and who

• have at least 3-year overall survival follow-up data available will be included consecutively.

Exclusion:

• Patients with neuroendocrine prostate cancer

• Patients with metastasized or disseminated malignancy other than prostate cancer

Statistical considerations:

This is an open registry study. The more data sets are contributed, the more precisely the diagnostic accuracy and prognostic value of PSMA PET can be determined for the overall cohort and subgroups.

Prognostic value of variables from PSMA-PET (PROMISE parameters, PSMA-Volume, Standardized Uptake Value (SUV) among other) and patient characteristics will be assessed by regression analysis and correlation analysis. Hazard ratio (95% Confidence Interval) and Concordance Index for the prediction of primary and secondary endpoints will be calculated. Primary endpoint is the association with overall survival. Secondary endpoints are the association with progression-free survival, management and other characteristics.

Central Database:

Data will be stored centrally in a RedCap Database with 3-step authentication at the sponsor site.

Recurring Data Entry:

Data entry will be conducted repeatedly at about 3 to 6 month intervals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 5, 2035
• Est. primary completion date: March 5, 2034
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion:

• Adult patients with

• biopsy/histo proven prostate cancer who

• underwent PSMA PET (any type)

• for staging or re-staging at any stage and who

• have at least 3-year overall survival follow-up data available will be included consecutively.

Exclusion:

• Patients with neuroendocrine prostate cancer

• Patients with metastasized or disseminated malignancy other than prostate cancer.

Related Conditions & MeSH terms

• PET/CT
• Prostate Cancer
• Prostatic Neoplasms
• Survivorship

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time from PSMA-PET until death	up to 10 years
Secondary	Metastasis-free survival	Time from PSMA-PET until development of new metastasis on any imaging	up to 10 years